Certain Recombinant Factor VIII Products; Institution of Investigation, 29745-29746 [2015-12390]

Download as PDF 29745 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices BURDEN TABLE Non-hour cost burdens NTL—Gulf of Mexico OCS region—GPS for MODUs Hour burden Average number of annual responses 1—Notify BSEE with tracking/locator data access and supporting information; notify BSEE Hurricane Response Team as soon as operator is aware a rig has moved off location. 15 mins ....... 15 mins ....... 1 rig * ......................... 1 notification * ............ 2—Purchase and install tracking/locator devices—(these are replacement GPS devices or new rigs). 3—Pay monthly tracking fee for GPS devices already placed on MODUs/rig ....... 4—Rent GPS devices and pay monthly tracking fee per rig .................................. 20 devices per year for replacement and/or new × $325.00 = $6,500 40 rigs at $50/month = $600/year = $24,000 40 rigs @$1,800 per year = $72,000 asabaliauskas on DSK5VPTVN1PROD with NOTICES Total burden ...................................................................................................... Estimated Reporting and Recordkeeping Non-Hour Cost Burden: We have identified three non-hour cost burdens for this collection, which are described and shown in the table. We have not identified any other non-hour cost burdens associated with this collection of information. Public Disclosure Statement: The PRA (44 U.S.C. 3501, et seq.) provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. Comments: Before submitting an ICR to OMB, PRA section 3506(c)(2)(A) requires each agency ‘‘. . . to provide notice . . . and otherwise consult with members of the public and affected agencies concerning each proposed collection of information . . .’’. Agencies must specifically solicit comments to: (a) Evaluate whether the collection is necessary or useful; (b) evaluate the accuracy of the burden of the proposed collection of information; (c) enhance the quality, usefulness, and clarity of the information to be collected; and (d) minimize the burden on the respondents, including the use of technology. Agencies must also estimate the nonhour paperwork cost burdens to respondents or recordkeepers resulting from the collection of information. Therefore, if you have other than hour burden costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. For further information on this burden, refer to 5 CFR 1320.3(b)(1) and (2), or contact the Bureau representative listed previously in this notice. VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 ..................... We will summarize written responses to this notice and address them in our submission for OMB approval. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB. Public Comment Procedures: Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment–including your personal identifying information–may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Dated: May 14, 2015. Douglas W. Morris, Chief, Office of Offshore Regulatory Programs. [FR Doc. 2015–12303 Filed 5–21–15; 8:45 am] BILLING CODE 4310–VH–P INTERNATIONAL TRADE COMMISSION [Investigation No. 337–TA–956] Certain Recombinant Factor VIII Products; Institution of Investigation U.S. International Trade Commission. ACTION: Notice. AGENCY: Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 16, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Baxter International Inc. of Deerfield, Illinois; Baxter Healthcare Corporation of Deerfield, Illinois; and Baxter Healthcare SA, of Switzerland. Letters supplementing the complaint were filed on April 21, 2015; May 1, 2015; and SUMMARY: PO 00000 Frm 00144 Fmt 4703 Sfmt 4703 102 responses ........... Annual burden hours 1 hour (rounded). 1 hour. May 4, 2015. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain recombinant factor VIII products by reason of infringement of certain claims of U.S. Patent No. 6,100,061 (‘‘the ’061 patent’’); U.S. Patent No. 6,936,441 (‘‘the ’441 patent’’); and U.S. Patent No. 8,084,252 (‘‘the ’252 patent’’). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders. The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205–2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal on (202) 205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205– 2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. ADDRESSES: The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205–2560. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\22MYN1.SGM 22MYN1 29746 Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10 (2015). Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on May 15, 2015, ordered that— (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain recombinant factor VIII products by reason of infringement of one or more of claims 19–21, 36, 37, and 39 of the ’061 patent; claims 20 and 21 of the ’441 patent; claims 1, 5, 8, 10, 14, and 18 of the ’252 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337; (2) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties and other interested persons with respect to the public interest in this investigation, as appropriate, and provide the Commission with findings of fact and a recommended determination on this issue, which shall be limited to the statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1) (3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served: (a) The complainants are: Baxter International Inc., One Baxter Parkway, Deerfield, IL 60015–4625. Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015– 4625. Baxter Healthcare SA, Thursgauerstrasse 130, Glattpark (Opfikon),Switzerland. (b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served: ´ Novo Nordisk A/S, Novo Alle, 2880 Bagsvaerd, Denmark. Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536. (c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; and (4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, VerDate Sep<11>2014 18:19 May 21, 2015 Jkt 235001 shall designate the presiding Administrative Law Judge. Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown. Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent. By order of the Commission. Issued: May 18, 2015. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2015–12390 Filed 5–21–15; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE [OMB Number 1140–0061] Agency Information Collection Activities; Proposed eCollection eComments Requested; Certification of Compliance Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice. ACTION: 60-day notice. AGENCY: The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: Comments are encouraged and will be accepted for 60 days until July 21, 2015. SUMMARY: PO 00000 Frm 00145 Fmt 4703 Sfmt 4703 If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Tracey Robertson, Tracey.Robertson@atf.gov, Chief, Federal Firearms Licensing Center, 244 Needy Road, Martinsburg, WV 25405. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of this information collection 1140–0061: 1. Type of Information Collection: Extension of an existing collection. 2. The Title of the Form/Collection: Certification of Compliance. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: Form number: ATF Form 5330.20. Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice. 4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. Other: None. Abstract: The law at 18 U.S.C. 922(g)(5)(B) makes it unlawful for any nonimmigrant alien to ship or transport in interstate commerce, or possess in or affecting commerce, any firearm, ammunition, which has been shipped or transported in interstate or foreign FOR FURTHER INFORMATION CONTACT: E:\FR\FM\22MYN1.SGM 22MYN1

Agencies

INTERNATIONAL TRADE COMMISSION

[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29745-29746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12390]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-956]


Certain Recombinant Factor VIII Products; Institution of 
Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that a complaint was filed with the 
U.S. International Trade Commission on April 16, 2015, under section 
337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of 
Baxter International Inc. of Deerfield, Illinois; Baxter Healthcare 
Corporation of Deerfield, Illinois; and Baxter Healthcare SA, of 
Switzerland. Letters supplementing the complaint were filed on April 
21, 2015; May 1, 2015; and May 4, 2015. The complaint alleges 
violations of section 337 based upon the importation into the United 
States, the sale for importation, and the sale within the United States 
after importation of certain recombinant factor VIII products by reason 
of infringement of certain claims of U.S. Patent No. 6,100,061 (``the 
'061 patent''); U.S. Patent No. 6,936,441 (``the '441 patent''); and 
U.S. Patent No. 8,084,252 (``the '252 patent''). The complaint further 
alleges that an industry in the United States exists as required by 
subsection (a)(2) of section 337.
    The complainants request that the Commission institute an 
investigation and, after the investigation, issue a limited exclusion 
order and cease and desist orders.

ADDRESSES: The complaint, except for any confidential information 
contained therein, is available for inspection during official business 
hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. 
International Trade Commission, 500 E Street SW., Room 112, Washington, 
DC 20436, telephone (202) 205-2000. Hearing impaired individuals are 
advised that information on this matter can be obtained by contacting 
the Commission's TDD terminal on (202) 205-1810. Persons with mobility 
impairments who will need special assistance in gaining access to the 
Commission should contact the Office of the Secretary at (202) 205-
2000. General information concerning the Commission may also be 
obtained by accessing its internet server at https://www.usitc.gov. The 
public record for this investigation may be viewed on the Commission's 
electronic docket (EDIS) at https://edis.usitc.gov.

FOR FURTHER INFORMATION CONTACT: The Office of Unfair Import 
Investigations, U.S. International Trade Commission, telephone (202) 
205-2560.


[[Page 29746]]


    Authority:  The authority for institution of this investigation 
is contained in section 337 of the Tariff Act of 1930, as amended, 
and in section 210.10 of the Commission's Rules of Practice and 
Procedure, 19 CFR 210.10 (2015).

    Scope of Investigation: Having considered the complaint, the U.S. 
International Trade Commission, on May 15, 2015, ordered that--
    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 
1930, as amended, an investigation be instituted to determine whether 
there is a violation of subsection (a)(1)(B) of section 337 in the 
importation into the United States, the sale for importation, or the 
sale within the United States after importation of certain recombinant 
factor VIII products by reason of infringement of one or more of claims 
19-21, 36, 37, and 39 of the '061 patent; claims 20 and 21 of the '441 
patent; claims 1, 5, 8, 10, 14, and 18 of the '252 patent, and whether 
an industry in the United States exists as required by subsection 
(a)(2) of section 337;
    (2) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), 
the presiding administrative law judge shall take evidence or other 
information and hear arguments from the parties and other interested 
persons with respect to the public interest in this investigation, as 
appropriate, and provide the Commission with findings of fact and a 
recommended determination on this issue, which shall be limited to the 
statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), 
(f)(1), (g)(1)
    (3) For the purpose of the investigation so instituted, the 
following are hereby named as parties upon which this notice of 
investigation shall be served:
    (a) The complainants are:

Baxter International Inc., One Baxter Parkway, Deerfield, IL 60015-
4625.
Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015-
4625.
Baxter Healthcare SA, Thursgauerstrasse 130, Glattpark 
(Opfikon),Switzerland.

    (b) The respondents are the following entities alleged to be in 
violation of section 337, and are the parties upon which the complaint 
is to be served:

Novo Nordisk A/S, Novo All[eacute], 2880 Bagsvaerd, Denmark.
Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536.

    (c) The Office of Unfair Import Investigations, U.S. International 
Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; 
and
    (4) For the investigation so instituted, the Chief Administrative 
Law Judge, U.S. International Trade Commission, shall designate the 
presiding Administrative Law Judge.
    Responses to the complaint and the notice of investigation must be 
submitted by the named respondents in accordance with section 210.13 of 
the Commission's Rules of Practice and Procedure, 19 CFR 210.13. 
Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be 
considered by the Commission if received not later than 20 days after 
the date of service by the Commission of the complaint and the notice 
of investigation. Extensions of time for submitting responses to the 
complaint and the notice of investigation will not be granted unless 
good cause therefor is shown.
    Failure of a respondent to file a timely response to each 
allegation in the complaint and in this notice may be deemed to 
constitute a waiver of the right to appear and contest the allegations 
of the complaint and this notice, and to authorize the administrative 
law judge and the Commission, without further notice to the respondent, 
to find the facts to be as alleged in the complaint and this notice and 
to enter an initial determination and a final determination containing 
such findings, and may result in the issuance of an exclusion order or 
a cease and desist order or both directed against the respondent.

    By order of the Commission.

    Issued: May 18, 2015.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2015-12390 Filed 5-21-15; 8:45 am]
BILLING CODE 7020-02-P

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